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Why all the negative after hours trading when the future indexes are all positive?
Merck is choosing between signing a deal with Halozyme for MDASE or risking a dealy in launch of Keytruda SC (i.e. loss of market share to BMY's opdivo SC) or even worse yet a delay in launch followed by a loss in the courtroom for patent infringements.
There is a 3rd option. Merck could buy halozyme out. No risk of a launch delay or unfavorable court ruling and no need to pay MDASE royalty if Merck owns halozyme. At a 2025 PE of 13 and PEG of 0.45, halo is such a bargain https://www.nasdaq.com/market-activity/stocks/halo/price-earnings-peg-ratios
And once Merck owns halozyme, it will be BMY that would be paying Merck for Enhanze royalties (for Opdivo SC) for a longtime to come.
"The multiple myeloma therapy, which brought in $11.7B net sales for J&J (JNJ) in 2024 ahead of its loss of market exclusivity in two years,..." The article is from Seeking Alpha. This may not affect Halo, though.
"Genmab (GMAB) ADRs traded lower on Tuesday after Bernstein downgraded the Danish biotech to Underperform from Market Perform, arguing that its stock has yet to fully reflect the upcoming patent cliff for the company’s blood cancer therapy Darzalex, marketed with J&J (JNJ).
The multiple myeloma therapy, which brought in $11.7B net sales for J&J (JNJ) in 2024 ahead of its loss of market exclusivity in two years, can lead to a threefold drop in GMAB’s group revenue in 2030-2040 under his base case, Bernstein analyst Justin Smith wrote.
Despite disappointing news about JNJ’s decision to opt out of HexaBody-CD38, a potential successor to Darzalex, Genmab (GMAB) shares have yet to fully discount the impact from the upcoming patent cliff, Smith added, citing his base case 2025–2029 EPS estimates for GMAB."
According to AI overview:
Darzalex (daratumumab) faces a loss of market exclusivity, with its patents expiring in 2027 in the US and 2026 in the EU, potentially leading to biosimilar competition.
Here's a more detailed breakdown:
Patent Expiration:
Darzalex's key US patents are set to expire in 2027.
The drug's patents are protected until 2026 in both the US and EU.
However, several other patents extend its exclusive protection until 2035.
Orphan Drug Exclusivity:
Darzalex has regular MP and ODE for the treatment of multiple myeloma, both of which will expire in May 2026.
Potential for Biosimilars:
The expiration of Darzalex's patents could pave the way for biosimilar versions of the drug to enter the market.
Darzalex Faspro:
Darzalex Faspro, a subcutaneous formulation of Darzalex, also has patents that are set to expire in 2035.
Halozyme Therapeutics (NASDAQ: HALO) announced that Bristol Myers Squibb received a positive CHMP opinion recommending approval for a new subcutaneous formulation of Opdivo® (nivolumab) developed with ENHANZE® technology across multiple adult solid tumor indications in the EU.
The subcutaneous formulation, which utilizes Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), would offer cancer patients a faster and more flexible treatment option. The European Commission's decision on marketing authorization is expected by June 2, 2025.
The recommendation is supported by positive Phase 3 CheckMate -67T trial results. The formulation was previously approved in the U.S. on December 27, 2024 under the brand name Opdivo Qvantig.
Halozyme's announcement of Bristol Myers Squibb receiving a positive CHMP opinion for subcutaneous Opdivo utilizing ENHANZE® technology represents a significant commercial advancement for Halozyme's drug delivery platform. This recommendation encompasses multiple solid tumor indications and builds upon the December 2024 FDA approval of Opdivo Qvantig in the U.S.
This development validates Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20) platform as a facilitator for subcutaneous administration of traditionally intravenous biologics. For Halozyme, each commercial implementation of ENHANZE typically generates tiered royalties on net sales plus potential milestone payments, though specific financial terms for this particular agreement weren't disclosed.
The subcutaneous formulation offers substantial clinical advantages including reduced administration time compared to IV infusions, potentially expanding Opdivo's competitive positioning against rival checkpoint inhibitors. With European Commission approval expected by June 2, 2025, this represents a near-term potential revenue catalyst for Halozyme.
Bristol Myers Squibb's Phase 3 CheckMate -67T trial provided the efficacy and safety data supporting this recommendation, suggesting the subcutaneous formulation maintained Opdivo's therapeutic profile while offering administration benefits. For Halozyme, this advancement bolsters its technology's commercial viability in high-value oncology applications while potentially reducing healthcare resource utilization – a key selling point for future ENHANZE partnerships.
https://www.stocktitan.net/news/HALO/halozyme-announces-bristol-myers-squibb-received-positive-chmp-57liwjmgzun2.html
AI (Grock):
"Probability Assessment:- Base Case (60%): Merck opts for a licensing deal to secure the 2026 launch and avoid risk. This assumes the PGR process or litigation threat creates enough uncertainty to favor settlement, and Halozyme offers reasonable terms. The pharma industry’s tendency to settle high-stakes disputes supports this.- Alternative Case (40%): Merck fights and wins, either invalidating the patents or proving non-infringement. This hinges on strong PGR outcomes or a favorable court ruling, bolstered by Merck’s resources and Alteogen’s enzyme differentiation.
Balancing these, I’d assign a 65% probability that Merck signs a licensing agreement with Halozyme. The edge comes from Merck’s need for speed and Halozyme’s licensing track record, though Merck’s aggressive PGR strategy introduces notable uncertainty. If the PTAB denies PGR institution (mid-2025) or Halozyme pushes hard on litigation, this could shift toward a deal; if Merck gains early wins, it might drop below 50%. For now, 65% feels like a reasoned bet on pragmatism prevailing."
52 week low for the XBI.
We're(HALO longs) doing pretty good.
We are almost into the second quarter of 2025 and still waiting for the HVAI that Helen had forecasted for 2023.
Is the impressive share price action due to the anticipation of 1) HVAI deal, 2) phenomenal valuations (PE/ PEG ratios and growing earnings and profit margins) or 3) anticipation of a win against Merck?
I think the former 2 reasons are more likely.This week we had a couple of articles that made me think a halozyme win might not be such a slam dunk (I still think that halo is more likely to win) and yet stock is acting well.
Great article. Wish I could understand it.
BRIEF-Merck Says FDA PDUFA Date For Subcutaneous Pembrolizumab Set For Sept 23
"While Merck and Alteogen could face a potential patent challenge from biotech Halozyme Therapeutics (HALO.O), over the enzyme, Merck said it will not delay the launch of the drug.
"We believe we have a very strong position relative to the claims from Halozyme," Merck's Monahan said."
https://www.reuters.com/business/healthcare-pharmaceuticals/merck-plans-us-launch-subcutaneous-version-keytruda-october-1-2025-03-27/
https://www.markmanadvisors.com/blog/2025/3/27/w7lv67t4yzfvbmrph1blwz17mkbee0
It's hard to say who will win the post-registration dispute but even if Merck wins that round, that will take care of only 7 of more than 100 applicable patents that Merck is infringing.
Does anyone have a copy of halozyme's 2012 priority application for patent 11,655,600?
Howee, that was a little early for your April Fools joke. LOL!
Because I originally thought that Merck and halo were testing Enhanze in the past. It looks like that wasn’t the case. It was pegph20 and not Enhanze.
Why would you post a 10 year old article?
I'm totally confused??????
It is certainly exhibiting strength on a day where xbi, ibb and big pharma were all very weak. And
alteogen has dropped 18% in the past 5 days.
Right, 2015. Disregard.
This is a 10 year old article ??
That is weird. HALO is sponsoring it.
Looks like wasn’t Enhanze but Pegph20.
Another strong finish with high volume. No option expiry to explain this one.
It's Dr. Torley.
Enjoy the gift from Mr. Market. Buying dips equally enjoyable as hitting 52 week and all time new highs.
Congratulations biotechinvestor 1
Congratulations Ms. Torley!!
I blinked and missed it. Maybe it will come around again today. Love these numbers!!!!!
There it is! New all time high. :)
Well, since they had the whole week to release the news, it does suggest that they tried to keep it under the radar. Also, I find the wording a bit odd -- very terse and a bit ambiguous. "His decision to retire from the company" suggests that he is going to stop working but not necessarily. Did he leave to pursue other opportunities or not?
Still, it's probably not something to be very concerned about.
Not strange at all. No one will know what happened here whether voluntary or involuntary but he clearly had success in the position. Be interesting to see his replacement.
Is it strange for HALO to put out an 8-k on Friday, March 21 at 4:03 pm, after the market closed for the week, regarding the March 17 retirement of Michael LaBarre?
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(b) On March 17, 2025, Michael J. LaBarre, Senior Vice President, Chief Technical Officer of Halozyme Therapeutics, Inc. (the “Company”) notified the Company of his decision to retire from the Company, effective March 17, 2025. The Company thanks Mr. LaBarre for his many years of service and contributions to the Company’s ENHANZE® drug delivery technology.
Michael LaBarre Biography and Net Worth
Chief Technical Officer of Halozyme Therapeutics
Dr. LaBarre brings to Halozyme more than 25 years of experience across all aspects of biopharmaceutical research and drug development, including strong expertise in chemistry, manufacturing, and controls (CMC), regulatory strategy and product development. Dr. LaBarre joined Halozyme in 2008 and has held leadership positions in product development, alliance management, research, and regulatory affairs during that time. He is currently responsible for providing scientific and technical leadership across all Halozyme programs and is the lead expert on Halozyme’s ENHANZE® drug delivery technology.
Prior to Halozyme, Dr. LaBarre served as Vice President of Product Development at Paramount BioSciences, LLC, where he led CMC and research efforts for the product development programs within Paramount’s portfolio companies. Prior to joining Paramount, Dr. LaBarre served from 1995 to 2006 in various research and development positions at Biogen Idec (formerly IDEC before the merger with Biogen in 2004), where he supported numerous IND and BLA submissions, including those for the commercial products RITUXAN® and ZEVALIN®. Prior to IDEC, Dr. LaBarre spent two years at Vical, Inc. and he began his career at Hybritech in San Diego in 1992. Dr. LaBarre also taught chemistry laboratory for several years as an adjunct professor at Mesa Community College early in his career.
Dr. LaBarre received his B.S. in Chemistry from Southampton College of Long Island University and his Ph.D. in Chemistry from the University of Arizona.
What is Michael J. LaBarre's net worth?
The estimated net worth of Michael J. LaBarre is at least $11.11 million as of February 27th, 2025. Dr. LaBarre owns 173,756 shares of Halozyme Therapeutics stock worth more than $11,114,303 as of March 21st. This net worth approximation does not reflect any other investments that Dr. LaBarre may own. Additionally, Dr. LaBarre receives a salary of $843,890.00 as Chief Technical Officer at Halozyme Therapeutics.Learn More about Michael J. LaBarre's net worth.
How old is Michael J. LaBarre?
Dr. LaBarre is currently 60 years old. There are 2 older executives and no younger executives at Halozyme Therapeutics. The oldest executive at Halozyme Therapeutics is Dr. Helen I. Torley M.B. Ch. B., M.R.C.P., President, CEO & Director, who is 61 years old. Learn More on Michael J. LaBarre's age.
Well at least these program stock sales will be gone. I’ll bet the day end volume has something to do with options expiration.
In the past five days, Halo has traded up whereas Alteogen, Mrk and Azn have all traded down. It may be a coincidence but maybe someone knows something.
It's nice to see fundamentals and value win over nonsense and noise.
It's fun to look at some of the old posts and predictions. Late November and early December, our IH board permabears were at it again with their doom and gloom posts; one of them predicting that halo will be dropping to $30's.
Some of us pointed to the PE and PEG ratios as the north star and opined that halo will be trading back in the $60's EVEN WITHOUT A SINGLE NEW DEAL.
Here we are, no new deal announced yet and we are in mid $60's. The earnings are growing so fast that we are still trading at PEG of 0.5 and forward 2025 PE of 13.5 which are incredible bargains. Imagine how much higher we can go when a HVAI deal is announced.
In my opinion, Halo's strong performance also points to a sense of confidence by institutional investors that halo will prevail against Merck (either a licensing agreement is signed or Merck loses in court)
That was one strong last 5 minutes.
Huge volume to the upside going into the weekend.
Have a great weekend everyone.
That was a beautiful close with volume and conviction. :)
New all time highs! Will it be today? Will it be next week? Will Mr. Market give us a dip to load up more?
All 3 possibilities sound great to me.
Still an amazing bargain with the following valuation metrics: https://www.nasdaq.com/market-activity/stocks/halo/price-earnings-peg-ratios ;
Price/Earnings Ratio
And some positive news in regards to Vyvart. Competitive threats matter. From JPM:
Argenx
Immunovant MG/CIDP Bato FcRn data doesn’t look like a significant competitive threat, another potential headwind dismissed.
Immunovant today reported Phase III/IIb MG and CIDP data for it’s first gen FcRn, Bato. Bato Phase III MG efficacy looks below Argenx’s Vyvgart, and bato Phase IIb CIDP data is hard to directly compare to Vyvgart, but bato also doesn’t seem to be better. In addition, there was limited disclosure on safety, but we assume bato will still have cholesterol issues not seen with Vyvgart, hence Immunovant’s focus on next generation FcRn IMVT-1402, theoretically cleaner, which is just starting Phase III, and Immunovant don’t plan to file bato for MG or CIDP. Given bato had been flagged as a potential competitive risk/negative read-through to Argenx Vyvgart in terms of Immunovant’s next gen IMVT-1402 on the back of this bato update, we see the absence of a superior bato profile as a positive for Argenx shares, removing what some had feared could be a significant competitive threat.
In not so good news: Trump Administration Wants to Cut HIV-Prevention Funding
https://www.barrons.com/articles/boeing-stock-outlook-investors-af96015c
Gilead Sciences
GILD
-2.96%
stock declined Wednesday after The Wall Street Journal reported the Department of Health and Human Services was considering federal funding cuts to domestic HIV prevention.
The Centers for Disease Control and Prevention, an arm of the HHS, has a Division of HIV Prevention dating back to the 1980s. In addition to tracking HIV infections across the country, it focuses on community outreach, working with state and local leaders to promote testing and prevention.
Congress enacted a spending bill in 2023 that appropriated nearly $1.4 billion to the CDC for HIV prevention and that of other infectious diseases. The Journal report comes amid a broader push by the Trump administration to slash federal spending.
Gilead stock fell 2.9% to $107.03 on Wednesday. The biotech focuses on virology, oncology, and inflammation, and brands itself the “long-standing leader” in HIV treatment. Gilead is the maker of Biktarvy and Descovy, two antiretroviral drugs used to prevent and treat the virus.
In January, the company settled a lawsuit with the CDC claiming Gilead refused to license the agency’s patents and ignored its contributions to the development of pre-exposure prophylaxis, or PrEP, a medication regimen that can help prevent HIV.
ViiV Healthcare, a multinational company specializing in the research and development of HIV treatments, also could be affected by funding cuts. ViiV is a joint venture of GSK
GSK
-1.57%
, Pfizer
PFE
-0.06%
, and Japanese pharma company Shionogi.
Write to Mackenzie Tatananni at mackenzie.tatananni@barrons.com
Sweet......now the news on the AI Deal between them, that Helen mentioned......IMO......
Acumen Pharmaceuticals Announces Topline Results from Phase 1 Study of Subcutaneous Formulation of Sabirnetug in Healthy Volunteers
https://investors.acumenpharm.com/news-releases/news-release-details/acumen-pharmaceuticals-announces-topline-results-phase-1-study
March 19, 2025 at 8:00 AM EDT
Download PDF
Weekly subcutaneous administration of sabirnetug was well-tolerated in the Phase 1 study
Systemic exposure following subcutaneous administration supports further clinical development
Development of sabirnetug delivered subcutaneously has the potential for decreased treatment burden and increased patient convenience
NEWTON, Mass., March 19, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AßOs) for the treatment of Alzheimer’s disease (AD), today announced topline results from its Phase 1 study comparing pharmacokinetics (PK) between subcutaneous (SC) and intravenous (IV) formulations of sabirnetug in healthy volunteers. Weekly SC administration of sabirnetug was well-tolerated with systemic exposure supporting further clinical development.
“We are pleased that the results of our initial clinical study support further clinical development of sabirnetug administered subcutaneously, underscoring the potential for increasing patient convenience of this formulation relative to intravenous treatment,” said Daniel O’Connell, Chief Executive Officer of Acumen. “The timely completion of this study highlights the strength of our clinical team and partners, and our commitment to advancing our clinical pipeline efficiently and effectively. Based on these data, we believe that further development of subcutaneous sabirnetug as a more convenient administration option for patients is warranted.”
The Phase 1 study in healthy volunteers enrolled 12 subjects who received single IV doses of 2,800 mg and 16 subjects who received four weekly SC doses of 1,200 mg. The most frequently reported adverse events included injection site reactions (62.5%), all of which were mild (Grade 1) in severity and resolved. No other safety signals were identified. Importantly, SC administration of sabirnetug produced sufficient systemic exposure to enable further clinical studies of SC dosing.
Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AßOs in patients with AD. The SC formulation of sabirnetug is co-formulated with Halozyme’s proprietary ENHANZE® drug delivery technology (recombinant human hyaluronidase enzyme, rHuPH20) that enables large volume SC injection with increased dispersion and absorption of co-administered therapies. ENHANZE® has been commercially validated as a component of nine approved therapies.
The Phase 2 ALTITUDE-AD study of IV sabirnetug is currently ongoing.
About Sabirnetug (ACU193)
Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AßOs), which are a highly toxic and pathogenic form of Aß, relative to Aß monomers and amyloid plaques. Soluble AßOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AßOs, sabirnetug aims to address the hypothesis that soluble AßOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer’s disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and is currently being evaluated in a Phase 2 study in patients with early AD.
About ALTITUDE-AD (Phase 2)
Initiated in 2024, ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug (ACU193) infusions administered once every four weeks in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease. The study will enroll approximately 540 individuals with early Alzheimer’s disease (mild cognitive impairment or mild dementia due to AD). The global study is currently ongoing at multiple investigative sites located in the United States, Canada, UK, and the European Union. More information can be found on www.clinicaltrials.gov, NCT identifier NCT06335173.
About Halozyme’s ENHANZE® Technology
Halozyme's commercially validated proprietary ENHANZE® drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume and delivery rates of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered rapidly in minutes subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections.
About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AßOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AßOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AßOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic Alzheimer’s disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “potential,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning the therapeutic potential and potential clinical efficacy of Acumen’s product candidate, sabirnetug (ACU193) and its subcutaneous formulation. l. These statements are based upon the current beliefs and expectations of Acumen’s management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of geopolitical events and macroeconomic conditions, such as rising inflation and interest rates, supply disruptions and uncertainty of credit and financial markets. These and other risks concerning Acumen’s programs are described in additional detail in Acumen’s filings with the Securities and Exchange Commission (“SEC”), including in Acumen’s most recent Annual Report on Form 10-K, and in subsequent filings with the SEC. Copies of these and other documents are available from Acumen. Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether, as a result of new information, future events or otherwise.
Investors:
Alex Braun
abraun@acumenpharm.com
Media:
Jon Yu
ICR Healthcare
AcumenPR@icrhealthcare.com
You can reach an agreement with both Halozyme and Alteogen from the beginning, but should you go through the hassle of signing a contract with Alteogen first and then with Halozyme later?
How many contracts has Halozyme had in the last few years? As far as I know, none.
He’s only been there a few years. I’m pretty sure I’ve heard these patents have been around much longer. Could be wrong but I’m sure someone out there knows when they were filed.
Similar to why Merck signed up with alteogen instead of Halo, it is likely that the oncology class of meds that astrazeneca wanted to convert to SC where unavailable with Enhanze due to exclusive contracts halozyme has with other partners already.
If so, AstraZenca is smart to first sign up with Alteogen and wait and see how the dust settles between Merck and Halozyme. However all signs so far point to a compelling argument by Halo and a likely settelment/licensing between Merck and Halo. Same will then happen with Halo and AstraZeneca. 
In a sense Alteogen is indirectly helping bring MDASE licensing customers to halozyme.
I know the permabears and the Alteogen investors will say why not sign up directly with halo's MDASE. The reason is simple, they don't just want the product, they also want the support and expertise that come with it. Since they can't get that from Enhanze (due to exclusivies mentioned above), they are going with Alteogen and waiting/hoping to see if Merck can get away with it.
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http://www.halozyme.com
Halozyme is a biopharmaceutical company developing and commercializing products based on the extracellular matrix for the drug delivery, oncology, and dermatology markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases.
The company's Enhanze Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its first partnership is with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets. In addition, the company has received FDA approval for two products: Cumulase® and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter Healthcare Corporation. The Company also has a number of different enzymes in its portfolio that are targeting significant areas of unmet need.
Halozyme is a therapeutically driven biopharmaceutical company developing and commercializing recombinant human enzymes to provide enhanced and innovative alternatives that improve the practice of medicine. Halozyme is focused on providing life-saving and life-enhancing solutions to the drug delivery, oncology, and dermatology markets.
Products/Pipeline
Halozyme is a therapeutically driven biopharmaceutical company developing and commercializing recombinant human enzymes to provide enhanced and innovative alternatives that improve the practice of medicine. Halozyme is focused on providing life-saving and life-enhancing solutions to the drug delivery, oncology, and dermatology markets.
The foundation of our capabilities is our recombinant human hyaluronidase enzyme, rHuPH20, which temporarily degrades hyaluronan, a structural protein in the interstitial space. This temporary alteration provides an opportunistic window that allows the delivery of injectable biologics such as monoclonal antibodies, as well as small molecules and fluids. With our enzyme, many pharmaceuticals that would normally be injected intravenously (IV) can be administered subcutaneously (SC). This change in route of delivery may improve patient convenience, enhance pharmacokinetics, boost efficacy, extend the product lifecycle, and reduce cost, in addition to other attributes.
Four key internal programs comprise our current proprietary product development portfolio. The endocrinology franchise consists of Insulin-PH20, which applies our PH20 enzyme to currently approved and marketed insulin products. The oncology franchise consists of PEGPH20, a new molecular entity administered intravenously that targets the external environment of tumor cells, and Chemophase, which utilizes the PH20 enzyme for local administration in bladder cancer. Our lead enzyme in the dermatology franchise, HTI-501, is a new molecular entity which digests collagen and may have applications in both medical and aesthetic dermatology such as cellulite.
Our product development pipeline also includes three distinct partnered programs with two companies; Roche and Baxter BioScience for Enhanze technology, and a partnership with Baxter Medication Delivery for Hylenex, our FDA-approved drug. These partnered programs validate our technology and may generate clinical and commercial milestone revenue based on the achievement of pre-specified events along with sales royalties when products reach the commercial stage. We utilize the cash milestone payments generated from the partnered programs as a source of development funding for our proprietary pipeline projects.
Endocrinology
Our endocrinology development activity focuses on insulin, a mainstay of treatment for people with diabetes. This program combines our PH20 hyaluronidase enzyme with insulin, a frequently prescribed, commercially successful pharmaceutical already approved and on the market.
We believe that the combination of our PH20 enzyme with existing, meal time insulin products such as regular insulin or a fast acting analog could lead to a best-in-class product that more closely mimics the release of natural insulin in the body. The results of a Phase 1 study, where we combined PH20 with Humulin® R (regular human insulin) and with Humalog® (insulin lispro), demonstrated significantly faster and higher insulin plasma concentrations compared to either insulin alone. Faster acting insulin could provide patient benefits such as reduced hypoglycemia, lower intra-subject variability, and less weight gain. These potential benefits would be significant but must first be demonstrated and proven in clinical development.
Our first Phase 2 clinical trial with insulin began in October 2008 and enrolled Type 1 diabetic patients. Data presented from our Phase 1 trial showed that the administration of regular insulin and an insulin analog with our PH20 enzyme led to faster insulin absorption and more rapid effects than either insulin alone. Our Phase 2 trial is designed to demonstrate similar results in Type 1 diabetic patients. We hope to present preliminary Phase 2 results at the American Diabetes Association meeting in June. Additional clinical trials are planned in 2009.
ONCOLOGY
Hyaluronan (HA) is a component of the extracellular matrix that frequently accumulates in human cancers. The quantity of HA produced by the tumor cells directly correlates with increased tumor growth and metastasis and it has been linked with tumor progression and poor prognosis. Previous clinical trials of bovine hyaluronidase showed promise in enhancing chemotherapy regimens using adjunctive systemic hyaluronidase in chemo-refractory patients. In animal studies the removal of HA from tumors with hyaluronidase has demonstrated improved survival, suppression of tumor growth, and enhanced efficacy of certain anti-cancer drugs. Chemotherapeutic agents may be able to better penetrate the tumor once the HA has been removed.
We have also observed significant reduction of tumor interstitial fluid pressure (IFP) following the administration of rHuPH20 in solid tumors grown in mice. Tumor interstitial pressure is widely believed to be an important factor limiting the access of cytostatic regimens to solid tumors. By digesting the HA gel, rHuPH20 may reduce IFP in the tumor and promote more effective delivery of chemotherapy throughout the tumor. This could potentially lead to better patient outcomes and increased survival.
Our PEGPH20 program utilizes pegylated hyaluronidase that allows for intravenous administration to degrade the HA that surrounds tumor cells. The Chemophase program applies the hyaluronidase enzyme along with mitomycin C directly into the bladder where the enzyme can hydrolyze the HA produced by the cancerous bladder cells. Unlike tumor cells, normal cells do not produce HA in this manner and appear not to be adversely affected by the enzyme.
We are investigating pegylated-rHuPH20, or PEGPH20, a new molecular entity, as a candidate for the systemic treatment of tumors rich in hyaluronan, or HA. Pegylation refers to the attachment of polyethylene glycol to our rHuPH20 enzyme, which extends its half life from less than 30 seconds to more than 24 hours. Numerous solid tumors, including prostate, breast, pancreas, colon and non-small cell lung, accumulate HA that forms a halo like coating over the surface of the tumor cell.
In preclinical studies, PEGPH20 has been shown to remove the HA coating surrounding several tumor cell lines. Treatment of PC3 (a prostate cancer cell line that produces HA) tumor bearing mice with PEGPH20 as a single agent demonstrated approximately 70% tumor growth inhibition relative to controls. Repeat dosing with PEGPH20 produced a sustained depletion of HA in the tumor microenvironment. For tumor models that do not produce HA, the presence of PEGPH20 has no effect. An estimated 20% to 40% of certain solid tumors may produce HA.
Administration of the combination of PEGPH20 with docetaxel or with liposomal doxorubicin in HA producing animal tumor models produced a significant survival advantage for the combination relative to either chemotherapeutic agent alone. Therefore, based on these animal studies and other tests conducted by Halozyme, PEGPH20 may represent a potentially innovative treatment approach against tumors that produce HA.
PEGPH20 recently started its first Phase 1 clinical trial which will evaluate the agent over a range of doses. The study will enroll up to 46 advanced cancer patients who will receive treatment cycles of intravenous PEGPH20 as a single agent twice weekly for three weeks followed by one week without dosing. Patients may continue subsequent cycles at their assigned dose as long as there is no tumor progression and no unacceptable toxicity. Groups of four to eight patients will be in each dosage cohort. The primary outcome measures of the study will be to evaluate safety and tolerability of PEGPH20 and to determine the recommended single agent Phase 2 dose. Secondary objectives will be to determine pharmacokinetics, obtain dose limiting toxicities, and observe patients for any evidence of anti-tumor activity.
Chemophase is a chemoadjuvant we have investigated for possible use in the treatment of patients with superficial bladder cancer, which represents a smaller potential market than our other proprietary pipeline opportunities. The Chemophase program combines our PH20 enzyme with mitomycin C, a cytotoxic drug, for direct administration into the bladder immediately after transurethral resection of bladder tumors (TURBT), a standard surgical treatment for the disease. Many bladder tumor cells produce high quantities of HA and thus treatment to remove the HA coating could increase their exposure to mitomycin C. This may lead to a lower recurrence of the cancer and a better prognosis for patients.
In June 2008, we announced the interim results of a Phase I/IIa clinical trial in which the Chemophase combination treatment of mitomycin C plus rHuPH20 enzyme was well tolerated and appears safe. The study reported no dose-limiting toxicities and no observed side effects attributable to the enzyme. An ongoing safety trial involves the immediate post operative (IPOP) administration of PH20 and mitomycin directly into the bladder of patients after a TURBT procedure.
DERMATOLOGY
The foundation of our dermatology program is HTI-501, a human lysosomal proteinase that degrades collagen. It may be useful in the treatment of both medical and aesthetic dermatologic conditions such as cellulite, Dupuytren’s contracture and Peyronie’s disease. This pH sensitive enzyme demonstrates activity under mildly acidic conditions but shows no activity at normal physiologic pH. This attribute may be harnessed to exert control over the duration and location of the enzyme’s therapeutic activity.
Tests with HTI-501 in several animal models have produced encouraging results and our pre-clinical investigations of the enzyme will continue throughout 2009.
ENHANZE
Enhanze™ Technology, a proprietary drug delivery platform using Halozyme’s first approved enzyme, rHuPH20, is our broader technology opportunity that can potentially lead to partnerships with other pharmaceutical companies. When co-formulated with other injectable drugs, Enhanze Technology may facilitate the penetration and dispersion of these drugs by temporarily opening flow channels under the skin.
Molecules as large as 200 nanometers may pass freely through the extracellular matrix, which recovers its normal density within approximately 24 hours, leading to a drug delivery platform which does not permanently alter the architecture of the skin. The principal focus of our Enhanze Technology platform is the use of rHuPH20 to facilitate subcutaneous or intramuscular routes of administration for large molecule biological therapeutics. We are seeking partnerships with pharmaceutical companies that market drugs requiring or benefiting from injection via the subcutaneous or intramuscular routes that could benefit from this technology. In December 2006, we signed our first Enhanze Technology partnership with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche, Inc. In September 2007, we signed our second Enhanze Technology partnership with Baxter Healthcare Corporation and Baxter Healthcare S.A.
HYLENEX
Full prescribing information is available below or at www.hylenex.com
Hylenex is a human recombinant formulation of rHuPH20 to facilitate the absorption and dispersion of other injected drugs or fluids. When injected under the skin or in the muscle, hyaluronidase can digest the hyaluronic acid gel, allowing for temporarily enhanced penetration and dispersion of other injected drugs or fluids. We filed a New Drug Application (NDA) in March 2005 and we received approval of our Hylenex NDA in December 2005.
Hylenex may facilitate subcutaneous delivery of fluids up to one liter without the need for intravenous access, a procedure known as EASI. Importantly, EASI for fluid replacement in terminal patients may be achieved with limited or no need for nursing assistance. Over 1.1 million subcutaneous fluid infusions are performed per year with hospice patients alone (Source: Company estimates based on National Hospice and Palliative Care Organization data, 2001). In addition, over 500 million infusion bags are utilized annually in the United States, some of which could potentially convert to EASI using Hylenex, giving rise to additional market potential (Source: B. Braun, 2003).
During January 2006, we completed the INcreased Flow Utilizing Subcutaneously-Enabled Lactated Ringer’s clinical trial, or INFUSE-LR study, which was designed to determine the subcutaneous (Sub-Q) infusion flow rate of Lactated Ringer’s solution with and without Hylenex, determine the Sub-Q infusion flow rate dose response to Hylenex over one order of magnitude of dose, and assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 54 volunteer subjects who received Sub-Q infusions simultaneously in both upper arms through 24 gauge catheters.
During October 2006, we completed the INcreased Flow Utilizing Subcutaneously-Enabled Morphine clinical trial, or INFUSE-Morphine study, which was designed to determine the time to maximal blood levels of morphine after subcutaneous administration with and without Hylenex, to determine the time to maximal blood levels after intravenous administration of morphine, and to assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 12 evaluable patients who received Sub-Q infusions.
For full prescribing information, visit www.hylenex.com or www.baxter.com.
CUMULASE
Cumulase is an ex vivo (used outside of the body) formulation of rHuPH20 to replace the bovine enzyme currently used for the preparation of oocytes (eggs) prior to IVF during the process of intracytoplasmic sperm injection (ICSI), in which the enzyme is an essential component. The enzyme strips away the hyaluronic acid that surrounds the oocyte. This allows the clinician to then perform the ICSI procedure, injecting the sperm into the oocyte. The FDA considers hyaluronidase IVF products to be medical devices subject to 510(k) approval and we filed our 510(k) application during September 2004.
We received FDA clearance in April 2005. We launched Cumulase in the European Union and in the United States in June 2005. We believe the total ICSI market consisted of an estimated 500,000 intracytoplasmic sperm injection cycles worldwide in 2005 (Source: CDC, 2001; ESHRE, 2002).
Visit www.cumulase.com for more information.
Informative Links
http://www.nasdaq.com/asp/Holdings.asp?FormType=Institutional&page=holdingssymbol=HALO&selected=HALO
(Institutional Holdings)
http://www.cnbc.com/id/15837275?q=HALO
(Big Block Holders from CNBC)
http://www.sec.gov/edgar/searchedgar/companysearch.html
(SEC filings search from SEC.gov Edgar)
http://www.nasdaqtrader.com/Trader.aspx?id=shortinterest (Short Interest)
http://www.newratings.com/main/search_result.m?section=search
(Analyst Ratings)
http://www.insidercow.com/history/company.jsp?company=HALO&B1=Search%21
(Insider Transactions)
http://clinicaltrials.gov/ct2/results?term=rhuph20
http://clinicaltrials.gov/ct2/results?term=hyaluronidase+%28human+recombinant%29
(Clinical Trials)
Clinicals & Partners
http://media.corporate-ir.net/media_files/irol/17/175436/120506RocheHalozymePR.pdf
Halozyme and Roche enter agreement for the application of Enhanze, a novel technology to improve drug delivery
http://media.corporate-ir.net/media_files/irol/17/175436/RocheHalozymeSCRIPPresentation.pdf
(Halozyme and Roche presents “Developing and Managing Strategic Alliances” at the SCRIP conference
May 15-16, 2007 Berlin, Germany)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1049931&highlight=
Baxter and Halozyme Announce Collaboration for Development of Subcutaneous GAMMAGARD LIQUID(TM) Administration Using Enhanze(TM) Technology
http://www.genengnews.com/news/bnitem.aspx?name=32185399
Baxter Presents Latest Clinical Trial Results of GAMMAGARD LIQUID Administered Subcutaneously (Enhanze 3-16-08)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=962993&highlight=
Halozyme and Baxter Expand Global HYLENEX Collaboration
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=IROL-secToc&TOC=aHR0cDovL2NjYm4uMTBrd2l6YXJkLmNvbS94bWwvY29udGVudHMueG1sP2lwYWdlPTU0NDgxMjkmcmVwbz10ZW5r (Feb. 12, 2008 Slide Show Presentation)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1093211&highlight=
Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1117082&highlight=
Halozyme Therapeutics Presents Favorable New Safety and Pharmacokinetic Data on rHuPH20 Enzyme Produced Via New Manufacturing Process at European Federation for Pharmaceutical Sciences
Halozyme Therapeutics Presents Findings on Combinations of rHuPH20 Enzyme With Bisphosphonates at the American Association for Cancer Research Conference
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1130327&highlight=
Halozyme Therapeutics Presents Pre-Clinical Studies on Dermal Remodeling With HTI-501, a Lysosomal Proteinase
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1147853&highlight=
http://www.baxter.com/about_baxter/news_room/news_releases/2008/03-16-08-gammagard_liquid.html
Phase I/II data showed that Enhanze Technology™ enabled subcutaneous administration of a monthly dose of GAMMAGARD LIQUID in patients with Primary Immunodeficiency
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1163612&highlight=Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability
Cheetah full ADA presentation
http://www.halozyme.com/images/ADA%202008%20Poster%20legal.pdf
Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1177539&highlight=
Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1170737&highlight=
Halozyme Therapeutics Begins Phase 2 Clinical Trial of Insulin With rHuPH20 in Type 1 Diabetic Patients
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1220870&highlight=
Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial and Selects Fourth Exclusive Biologic Target
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1233454&highlight=
Halozyme Therapeutics Begins Phase 1 Clinical Trial of Bisphosphonate Administered With rHuPH20 Enzyme
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1234643&highlight=
Halozyme Deprioritizes Bisphosphonate Program to Reallocate Resources to More Commercially Attractive Internal Programs
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1295922&highlight=
Phase III Trial Begins for GAMMAGARD LIQUID Plus rHuPH20 in Primary Immunodeficiency Patients
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1240232&highlight=
Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial With Second Biologic
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1244971&highlight=
Halozyme Therapeutics Presents Positive Pre-Clinical Single Agent Data for PEGPH20
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1248119&highlight=
AACR presentations show that PEGPH20 produces anti-cancer activity in models of breast, prostate, and brain metastases that produce hyaluronan
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1277960&highlight=
Phase 1 Study for Halozyme's Insulin-PH20 Published, Highlights Findings for Faster Acting Insulin Formulations |
|
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1293715&highlight=
Accelerated Insulin Pharmacokinetics and Improved Glycemic Control in T1DM Patients by
Coadministration of Prandial Insulin with Recombinant Human Hyaluronidase
http://www.halozyme.com/ADA%202009%20Poster%20v3%202.pdf
Halozyme Announces Roche Selects Fifth Exclusive Biologic Target
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1297519&highlight
Baxter and Halozyme Announce Completion of Patient Enrollment in Phase III Pivotal Trial of GAMMAGARD LIQUID(TM) with rHuPH20 Enzyme
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1307856&highlight=
First patient dosed in trial with third Roche biologic formulated with Halozyme’s recombinant human hyaluronidase enzyme
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1330295&highlight=
Baxter Announces the Commercial Launch of HYLENEX at ACEP for Use in Pediatric Rehydration |
Data from the First Pediatric Rehydration Study, INFUSE-PEDS 1, Published Today in Pediatrics |
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1338559&highlight=
Halozyme Announces Roche Doses First Patient in Phase 3 Clinical Trial with Subcutaneous Herceptin(R)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1344910&highlight=
Earnings Transcripts
http://seekingalpha.com/article/68609-halozyme-therapeutics-q4-2007-earnings-call-transcript?source=yahoo&page=1
Halozyme Therapeutics Q4 2007 Earnings Call Transcript
http://seekingalpha.com/article/76655-halozyme-therapeutics-inc-q1-2008-earnings-call-transcript?source=yahoo
Halozyme Therapeutics Inc. Q1 2008 Earnings Call Transcript
http://seekingalpha.com/article/90080-halozyme-therapeutics-inc-q2-2008-earnings-call-transcript?source=yahoo&page=1
Halozyme Therapeutics Inc. Q2 2008 Earnings Call Transcript
http://seekingalpha.com/article/106797-halozyme-therapeutics-inc-q3-2008-earnings-call-transcript?source=yahoo
Halozyme Therapeutics, Inc. Q3 2008 Earnings Call Transcript
http://seekingalpha.com/article/125929-halozyme-therapeutics-inc-q4-2008-earnings-call-transcript?source=trans_sb_previous
Halozyme Therapeutics, Inc. Q4 2008 Earnings Call Transcript
http://seekingalpha.com/article/171883-halozyme-therapeutics-inc-q3-2009-earnings-call-transcript?source=yahoo
Halozyme Therapeutics, Inc. Q3 2009 Earnings Call Transcript
Links to understanding Clinical results
http://www.boomer.org/c/p3/c02/c0210.html
http://health.yahoo.com/other-other/picomoles-per-liter-pmol-l/healthwise--stp1694.html
http://www.unc.edu/~rowlett/units/scales/clinical_data.html
http://www.bio.net/bionet/mm/immuno/2000-July/015983.html
http://www.boomer.org/c/p1/
http://www.merck.com/mmpe/sec20/ch303/ch303a.html
Shares Outstanding: 91,095,288
Float: 73.21M
http://www.deepcapture.com/
(O-T How the market is manipulated and companies destroyed)
Halozyme Therapeutics Inc.
11588 Sorrento Valley Road
Suite 17
San Diego, CA 92121
United States
Phone: 858-794-8889
Halozyme Contact
Robert H. Uhl
Senior Director Investor Relations
858.704.8264
ruhl@halozyme.com
(Disclaimer) Do your own DD and confirm anything said on this board.
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